GREAT - Good Response With Appropriate Treatment

Neoplasms Clinical Trial

Official title:

GREAT (Good Response With Appropriate Treatment) "Factors Influencing the Analgesic Response Over Time of the Oxycodone-Naloxone Association in Painful Cancer Patients"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02293785
• Other study ID #: DOL-IRFMN-6554
• Status: Recruiting
• Phase: N/A
• First received: November 13, 2014
• Last updated: January 29, 2016
• Start date: November 2014
• Est. completion date: February 2016

Study information

• Verified date: January 2016
• Source: Mario Negri Institute for Pharmacological Research
• Contact: Oscar Corli, MD
• Email: oscar.corli[@]marionegri.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines AgencyItaly: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The symptoms associated in advanced cancer patients and adverse events due to use of opioids have major influence on the state of health and quality of life of patients. The pain, in particular, is a symptom with severe negative impact and with a prevalence ranging between 33% and 64%, according to the stage of the disease, with values around 70-90% in advanced stages and metastatic.

The use of opioids, however, is usually associated with the appearance of common adverse events as drowsiness/sedation, constipation, nausea/vomiting, and dizziness. Some effects are self-limiting in the time for the appearance of tolerance while others, as constipation persist.

Several clinical studies have demonstrated that the association oxycodone-naloxone (OXN), which consists in the union between a molecule agonist and an antagonist of opioid receptors, reduced the constipation in the presence of unchanged analgesic efficacy compared to oxycodone alone.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with diagnostic (histological or cytological) evidence of locally advanced or metastatic solid tumour;

• With average pain intensity > 4, measured with NRS and related to the last 24 hours, due to the cancer, requiring OXN for the first time;

• With life expectancy > one month;

• Strong opioid naïve;

• Eligible to take any of the medications under evaluation;

• With age = 18 years.

Exclusion Criteria:

• With presence of other diseases, including psychiatric/mental illness, severe senile or other form of dementia, that can interfere with participation and compliance with the study protocol or can contraindicate the use of the investigational drugs;

• Diagnosis of primary brain tumor or leukaemia;

• Diagnosis of chronic renal failure;

• Patients with antalgic radiotherapy or radio-metabolic therapy in progress or completed less than 14 days before study;

• Patients starting a first line chemotherapy simultaneously to the beginning of the study;

• Other types of analgesic treatments, including local-regional anesthetic techniques or neurosurgical /ablative methods;

• Patients who cannot guarantee regular follow-up visits for logistic or geographic reasons.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer Pain
• Neoplasms

Intervention

Drug:
• Oxycodone-Naloxone

Locations

Country	Name	City	State
Italy	IRCCS Centro di Riferimento Oncologico di Aviano	Aviano
Italy	Ospedale degli Infermi di Biella	Biella
Italy	Ospedale Oncologico A. Businco	Cagliari
Italy	E.O. Ospedali Galliera Genova	Genova
Italy	Presidio Ospedaliero di Macerata	Macerata
Italy	IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico di Milano	Milano
Italy	Istituto Scientifico San Raffaele	Milano
Italy	Ospedale di Mirano	Mirano
Italy	Ospedale V. Monaldi	Napoli
Italy	IRCCS Istituto Oncologico Veneto	Padova
Italy	Ospedale di Piacenza	Piacenza
Italy	Fondazione PTV Policlinico Tor Vergata	Roma
Italy	Ospedale San Camillo Forlanini	Roma
Italy	Policlinico Umberto I	Roma
Italy	Policlinico Umberto I Università Sapienza	Roma
Italy	A.O. Valtellina e Valchiavenna	Sondalo
Italy	Ospedale SS Trinità - Sora	Sora
Italy	Hospice "Raggio di Sole" SPA TP2	Trapani

Sponsors (1)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Corli O, Montanari M, Greco MT, Brunelli C, Kaasa S, Caraceni A, Apolone G. How to evaluate the effect of pain treatments in cancer patients: results from a longitudinal outcomes and endpoint Italian cohort study. Eur J Pain. 2013 Jul;17(6):858-66. doi: 10.1002/j.1532-2149.2012.00257.x. Epub 2012 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	non responders	Subjects will be classified as non-responders (NR) to treatment if between from the first and to last visit during the follow-up will not exhibit a reduction in average pain at least 30% and/or do not reach a final score of = 4 pain points, defined as average pain experienced in the last 24 hours and measured by an 11-point numerical scale from 0 (no pain) to 10 (maximum pain imaginable).	28 days	No
Secondary	Opioids Escalation Index	Percentage of subjects that will need during the follow-up an increase in daily opioid dose =5%, measured by the OEI% (Opioids Escalation Index). The value of 5% identifies the cut-off between the increases of dose considered normal or high entity.	28 days	No
Secondary	additional opioid treatment	Proportion of subjects that will need during the follow-up of an action to "additional" opioid treatment, in addition to the basic treatment programmed, to maintain the analgesic response in the treatment "around the clock".	28 days	No